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INCB009471
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
Ensayo de INCYTE CORP en Infeccion por VIH.
Más ensayos de: Infección por VIH.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 45
- Centros
- 6
- Fin del objetivo primario
- sep 2007
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en oct 2006.
Qué mide
Safety and tolerability will be assessed by monitoring adverse experiences. (Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not currently on a HAART regimen and have not received any antiretroviral agents for 3 months prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead electrocardiograms, physical examinations and virologic assessments, including viral load, viral tropism and CD4+ cell count determinations will be performed at the Screening visit and at regularly scheduled visits throughout the study. A blood sample will also be obtained and stored to potentially determine the genotype of the CCR5 receptor. The primary objectives are: 1. Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days; 2. Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days; 3. Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days
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Todos los de INCY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00393120), actualizada en mar 2018.